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Clinical Trials/NCT05557500
NCT05557500Not yet recruitingNot Applicable

Assessment of Psychological Symptoms and Quality if Life Among Fibromyalgia Patients and Its Risk Factors

Assiut University0 sites40 target enrollmentStarted: September 25, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Primary Endpoint
Evaluate prevelance of psychiatric disorders among fibromyalgia patients

Study Overview

Brief Summary

Fibromyalgia is a syndrome characterized by chronic widespread pain at multiple tender points, joint stiffness, and systemic symptoms (e.g., mood disorders, fatigue, cognitive dysfunction, and insomnia) [14] without a well-defined underlying organic disease. Nevertheless, it can be associated with specific diseases such as rheumatic pathologies, psychiatric or neurological disorders, infections, and diabetes.

The prevalence of fibromyalgia has been estimated to be around 1%-2% (3.4% for women and 0.5% for men) [5, 6].

Detailed Description

The etiology and pathogenesis of fibromyalgia are still not fully understood. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved.

diagnosis is principally based on the two major diagnostic criteria defined by the ACR in 1990 [7]: (1) a history of widespread musculoskeletal pain present for at least three months, and (2) tenderness in at least 11 of 18 defined tender points

Psychiatric problems seem to contribute considerably to the development of fibromyalgia. The prevalence of psychiatric conditions among patients affected by fibromyalgia is higher than among subjects complaining of other rheumatic diseases . The most common disorders associated are anxiety, somatization, dysthymia, panic disorders, posttraumatic stress, and overall depression [8]. Depression is more frequently associated with fibromyalgia than with other musculoskeletal diseases [9] Depression worsens fibromyalgic symptoms and vice versa, and antidepressants represent a cornerstone of fibromyalgia therapy [1011].

Over the last decade, it has been repeatedly shown that noninvasive repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) induces analgesic effects both in experimental pain [1216] , probably by activating pain modulation systems.

Another way studied to relieve fibromyalgia pain is sphenopalatine ganglion block

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women aged from 18 to 60 years old Diagnosed as fibromyalgia with resistence to pharmacological treatment

Exclusion Criteria

  • Previous psychiatric disorders Sever cognitive dysfunction Other medical or neurological disorders Pregnant females

Outcomes

Primary Outcomes

Evaluate prevelance of psychiatric disorders among fibromyalgia patients

Time Frame: 3 years

Identify possible risk factors that lead to psychiatric illness in fibromyalgia patients Evaluate effect of non pharmacological treatment in form of sphenopalatine ganglion block and transcranial mag netic stimulation on psychiatric symptoms in fibromyalgia patients

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

CA Adeeb

Principal investigator

Assiut University

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